Identifying MSI Status From ctDNA in Chinese Patients With Refractory Advanced Solid Tumors (IMPACT)

Identifying Microsatellite Instability Status From Circulating Tumor DNA in Chinese Patients With Refractory Advanced Solid Tumors: a Large Molecular Epidemiological Investigation

This is a molecular epidemiological investigation aiming to identify microsatellite instability status from circulating tumor DNA in Chinese patients with refractory advanced solid tumors.

Study Overview

• Status: Unknown
• Conditions: Solid Tumor
• Intervention / Treatment: Diagnostic test: SPANOM (identifying MSI status from ctDNA)

Detailed Description

This study is conducted in Chinese patients with advanced refractory metastatic solid tumors. A total of 8-10 mL of blood will be collected from eligible patients and used for extracting circulating tumor DNA. Blood-MSI status will be tested based on SPANOM technique developed by 3D Medicines Inc. Shanghai, China. Patients are encouraged to provide tissues collected from progressive disease for tissue-MSI testing (not required for inclusion).

• Study Type: Interventional
• Enrollment (Anticipated): 8000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Beijing Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female, age≥18 years old.
2. Confirmed malignant solid tumor by histopathology or cytopathology.
3. Colorectal cancer: progression after second-line therapy. Non-colorectal cancer: progression after first-line therapy.
4. Time duration from the last time of anti-cancer treatment to blood sample collection for MSI testing ≥ two weeks or five times half-life period of anti-cancer drugs
5. Signed the informed consent with name and time.

Exclusion Criteria:

1. Hematological malignancy
2. Patients who received immuotherapies.
3. Patients who received blood transfusion within one month before blood collection.
4. Pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; A total of 8-10 mL of blood will be collected from this group of patients and used for blood-MSI testing.	Diagnostic test: SPANOM (identifying MSI status from ctDNA); SPANOM technique, which has been developed by 3D Medicines Inc. Shanghai, China and made it possible to identify MSI status from blood samples, will be used in patients with refractory advanced solid tumors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of MSI-H across different cancer types in Chinese patients	Two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Lynch syndrome across different cancer types		Two years
Concordance between blood-MSI and corresponding tissue-MSI status	In patients who are able to provide tumor tissue samples, concordance between blood-MSI status by SPANOM technique and tissue-MSI status by polymerase chain reaction (PCR) method will be calculated. DNA extracted from each tumor tissue will be amplified by standard PCR using six microsatellite loci: NR-21, BA-26, NR-27, BA-25, NR-24, MONO-27. Tumors are designated MSI-H if more than two loci were instable, MSI-L if one locus is instable, and MSS if all loci are stable.	Two years

Collaborators and Investigators

• Sponsor: Peking University
• Investigators: Principal Investigator: Shen Lin, Professor, Peking University

Publications and helpful links

General Publications

• Zhenghang Wang, Hao Qin, Mei Wang, et al. SPANOM: A cost-effective method of detecting MSI in ctDNA. ASCO 2018, abstract e24263.

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2018
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: June 27, 2018
• First Submitted That Met QC Criteria: July 12, 2018
• First Posted (Actual): July 24, 2018

Study Record Updates

• Last Update Posted (Actual): July 24, 2018
• Last Update Submitted That Met QC Criteria: July 12, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: China; Solid tumor; ctDNA; MSI
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: IMPACT-China

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No